Proton pump inhibitor capsule and preparation method thereof

A technology of proton pump inhibitors and capsules, which is applied in the field of proton pump inhibitor capsules and its preparation, can solve the problems of complex production process of proton pump inhibitors, unstable drug release process, large adverse reactions, etc., and is suitable for mass production Preparation, inhibition of hypersecretion of gastric acid, and effect of improving gastrointestinal diseases

Active Publication Date: 2022-03-18
SUZHOU CHUNGHWA CHEM & PHARMA IND
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Therefore, the technical problem to be solved by the present invention is that the production process of existing proton pump inhibitors is complex and not stable enough, the drug release process is unstable, and the adverse reactions are large, etc. defect, and then provide a kind of proton pump inhibitor capsule and preparation method thereof

Method used

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  • Proton pump inhibitor capsule and preparation method thereof
  • Proton pump inhibitor capsule and preparation method thereof
  • Proton pump inhibitor capsule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0045] This embodiment provides a proton pump inhibitor capsule, including a capsule shell and enteric-coated microtablets, and the materials of the enteric-coated microtablets are shown in Table 1 below:

[0046] Table 1 Example 1 enteric-coated microtablet ingredients and dosage

[0047]

[0048] The specific preparation method is as follows:

[0049] (1) Omeprazole magnesium is premixed with Coptidis rhizome powder and calcined corrugated seed powder, then microcrystalline cellulose and glyceryl monostearate are mixed, and finally magnesium stearate is mixed for subsequent use;

[0050] (2) HPMC K4M and lactose are put into wet granulation, and after drying, the water content is controlled within 5%, and then magnesium stearate is put into the granules for final mixing for later use;

[0051] (3) Take steps (1) and (2) to obtain the pre-product, and use a rotary tablet press to compress the tablet to obtain the micro-tablet body, with a diameter of 0.5-5mm, a tablet th...

Embodiment 2

[0055]This embodiment provides a proton pump inhibitor capsule, including a capsule shell and enteric-coated microtablets, and the materials of the enteric-coated microtablets are shown in Table 2 below:

[0056] Table 2 Example 2 enteric-coated microtablet ingredients and dosage

[0057]

[0058] The specific preparation method is as follows:

[0059] (1) Lansoprazole sodium is premixed with gentian powder and calcined corrugated seed powder, then put into microcrystalline cellulose and carnauba wax and mix, finally drop into magnesium stearate and mix for subsequent use;

[0060] (2) Putting chitosan and dextrin into wet granulation, controlling the moisture within 5% after drying, and then putting magnesium stearate into the granules for final mixing for subsequent use;

[0061] (3) Take steps (1) and (2) to obtain the pre-product, and use a rotary tablet press to compress the tablet to obtain the micro-tablet body, with a diameter of 0.5-5mm, a tablet thickness of 1-5m...

Embodiment 3

[0065] This embodiment provides a proton pump inhibitor capsule, including a capsule shell and enteric-coated microtablets, and the materials of the enteric-coated microtablets are shown in Table 3 below:

[0066] Table 3 Example 3 enteric-coated microtablet ingredients and dosage

[0067]

[0068] The specific preparation method is as follows:

[0069] (1) Pantoprazole Sodium is premixed with Coptidis Rhizoma Coptidis powder, calcined corrugated seed powder, then drop into microcrystalline cellulose and glyceryl monostearate and mix, finally drop into magnesium stearate and mix for subsequent use;

[0070] (2) Carbomer 940 and lactose are put into wet granulation, and after drying, the water content is controlled within 5%, and then magnesium stearate is put into the granules for final mixing for later use;

[0071] (3) Take steps (1) and (2) to obtain the pre-product, and use a rotary tablet press to compress the tablet to obtain the micro-tablet body, with a diameter of...

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Abstract

The invention discloses a proton pump inhibitor capsule, which comprises a capsule shell and an enteric-coated micro-tablet, the enteric-coated micro-tablet comprises a coating and a micro-tablet body, the micro-tablet body is of a double-layer structure, and comprises a proton pump inhibitor sustained-release layer and a biological adhesion layer, the proton pump inhibitor sustained-release layer mainly comprises a drug component and a traditional Chinese medicine stabilizer, and the biological adhesion layer mainly comprises a drug component and a traditional Chinese medicine stabilizer. Alkaline traditional Chinese medicine is used as a stabilizer, and the raw materials are adsorbed and wrapped by using rough and porous microstructures of powder particles, so that the raw materials are kept in a shading and non-acidic environment; the proton pump inhibitor sustained release layer is a skeleton type sustained release tablet; the biological adhesion layer has a biological membrane adhesion function, and can ensure that the micro-tablet is retained in the small intestine to continuously release drugs. The invention further provides a preparation method of the proton pump inhibitor capsule, a direct mixing process is adopted during preparation, introduction of a solvent is avoided, high-temperature and high-humidity production conditions are avoided, and compared with other products in the market at present, the preparation method is simpler in production process and more suitable for mass production.

Description

technical field [0001] The invention relates to the field of medicament preparation, in particular to a proton pump inhibitor capsule and a preparation method thereof. Background technique [0002] Peptic ulcer is a common gastrointestinal disease. It generally refers to the ulcer formed by the gastrointestinal mucosa being digested by gastric digestive juice under certain circumstances. It often occurs in the esophagus (near the stomach), stomach, and duodenum. Wait. There are various reasons for the formation of ulcers, among which the digestive effect of gastric acid on the mucous membrane is the basic factor for the formation of ulcers. Peptic ulcer is a very common chronic disease of the digestive system. According to epidemiological data, about 10% to 12% of the population has suffered from gastric or duodenal ulcers. With the aging of the global population, The number of patients with peptic ulcer continues to increase. [0003] Proton pump inhibitors are currently...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K31/4439A61K35/618A61K36/515A61K36/718A61K47/38A61K47/36A61K47/32A61K47/26A61P1/04
CPCA61K9/4808A61K9/2866A61K9/2095A61K9/2054A61K9/205A61K9/2027A61K9/2018A61K36/718A61K36/515A61K35/618A61K31/4439A61P1/04A61K2300/00
Inventor 刘义龙
Owner SUZHOU CHUNGHWA CHEM & PHARMA IND
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